The Impact of an Evidence-Based Bundle on Cesarean Section-Related Surgical Site Infections: A Randomized Clinical Trial

IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY
Aditya Gan, Romana Khursheed, Mahadevi Savanur, Anita Dalal, Arif Maldar
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Abstract

To compare the effectiveness of an evidence-based bundle in minimizing cesarean section (CS)-related surgical site infections (SSIs) with that of standard routine care. This was a single-center, parallel, and randomized clinical trial conducted at KAHER’s Dr. Prabhakar Kore Charitable Hospital, Belagavi, India, from January 2021 to December 31, 2021. Three hundred twenty women undergoing CS delivery were selected and allocated into two groups (1:1) using simple randomization with fixed allocation. An evidence-based surgical bundle (a combination of more than three perioperative interventions) was used for the interventional group, whereas the control group received routine standard perioperative care. The primary outcome was the incidence of SSI (superficial, deep, and organ or space SSIs) within 6 weeks postpartum in both groups. Categorical and continuous data were analyzed using appropriate statistical tests with a significance threshold set at P < 0.05. In this study, 16 and 17 participants each from the control and intervention groups, respectively, were lost to follow-up, resulting in a total of 144 and 143 study participants included in the respective groups. Twenty-eight (19.4%) and 14 (9.7%) women developed SSI in the control and intervention groups, respectively (P = 0.02). Methicillin-resistant Staphylococcus aureus was the most common cause of SSI in both groups (63.6% (7/11) and 100% (3/3) in the control and intervention groups, respectively). The use of the evidence-based bundle for CS-related SSI prevention effectively decreased the incidence of SSI by half compared to standard routine practice. Implementing the use of this bundle in routine perioperative care will reduce the cost of CS and improve health outcomes in CSs. Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2020/11/029246.
循证捆绑包对剖宫产手术相关手术部位感染的影响:随机临床试验
比较循证捆绑疗法与标准常规护理在最大程度减少剖宫产手术(CS)相关手术部位感染(SSI)方面的效果。 这是一项单中心、平行和随机临床试验,于 2021 年 1 月至 2021 年 12 月 31 日在印度贝拉加维的 KAHER's Dr. Prabhakar Kore 慈善医院进行。采用固定分配的简单随机化方法,选取了 32 名接受 CS 分娩的产妇,并将其分配到两组(1:1)。干预组采用循证手术包(三种以上围手术期干预措施的组合),而对照组则接受常规标准围手术期护理。主要结果是两组产后 6 周内 SSI(浅表、深部、器官或间隙 SSI)的发生率。采用适当的统计检验对分类和连续数据进行分析,显著性阈值设定为 P <0.05。 在这项研究中,对照组和干预组分别有 16 名和 17 名参与者失去了随访机会,因此两组分别共有 144 名和 143 名参与者。对照组和干预组分别有 28 名(19.4%)和 14 名(9.7%)妇女出现 SSI(P = 0.02)。耐甲氧西林金黄色葡萄球菌是两组中最常见的 SSI 病因(对照组和干预组分别为 63.6%(7/11)和 100% (3/3))。 与标准常规做法相比,使用循证捆绑包预防 CS 相关 SSI 有效地将 SSI 发生率降低了一半。在常规围手术期护理中使用该捆绑疗法将降低 CS 的成本并改善 CS 的医疗效果。 印度临床试验注册中心 (www.ctri.nic.in)。注册编号:CTRI/2020/11/029246.
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来源期刊
Maternal-Fetal Medicine
Maternal-Fetal Medicine OBSTETRICS & GYNECOLOGY-
CiteScore
1.50
自引率
10.00%
发文量
119
审稿时长
10 weeks
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